Medical Equipment Approvals

Teleconformity offers guidance and registration services for Medical Equipment classified as non-invasive, low risk electric or electronic Equipment.


European Medical Devices Regulation 2017/745 (MDR)

The new European Medical Devices Regulation 2017/745 (MDR) was published in the OJ on 5 May 2017 and came into force on 25 May 2017. On 26 April 2020, the new Medical Device Regulation 2017/745 (MDR) will replace the Medical Device Directive 93/42/EEC, including the directive on Active Implantable Medical Devices 90/385/EEC (AIMDD). Please pay high attention to the transition period and validity of your currently declared or certified products.

Under the current (outphasing) Medical Devices Directive 93/42/EEC (MDD), Class I equipment does not require a Notified Body and can be authorized by a EC DoC procedure. The EC DoC must be issued by a European legal entity. After testing according the appropriate standards, in most cases EN60601-1 (Safety) and EN60601-1-2 (EMC), a correct Technical File (TF) including Risk Assessment (ref. EN/ISO 14971) shall be compiled. The European Commission maintains a list of currently harmonized standards. When releasing a class I non sterile medical device under EC DoC, only harmonized standards shall be used. The MDD has been amended by 2007/47/EC.

Equipment Classification:
Class I - Low Risk (non-sterile/non-measuring: Annex VII)
Class I - Low Risk (sterile/measuring: Annex VI or VII+IV)
Class IIa - Medium Risk (Annex II-section 4; Annex VII+IV/V/VI)
Class IIb - Medium Risk (Annex II-section 4; Annex III+IV/V/VI)
Class III - High Risk (Annex II+section 4; Annex III+IV/V )

Conformity Assessment:
Annex II: Full QA (EN/ISO 13485 or similar)
Annex III: EC Type Examination (3rd party testing required)
Annex IV: EC Verification
Annex V: Production QA (EN/ISO 13485)
Annex VI: Product QA (EN/ISO 13485)
Anenx VII: EC DoC (self declaration + risk assessment; only for Class I or Class IIa)

Continuous compliance:
Post Market Surveillane is required for all devices

The RULES CLASSIFICATION of the new European Medical Devices Regulation 2017/745 (MDR) shows in Annex VIII.

United States

Medical Equipment in the US may require approval from the Food and Drug Administration (FDA).

Canada

Medical Equipment in Canada may require approval from Health Canada.

Japan

Medical Equipment in Japan may require PMDA / PAL approval.


Australia

Class I Medical Equipment in Australia falls under the Therapeutic Goods Regulations of 2002 and must comply with the Australian Regulatory Guidelines for Medical Devices (ARGMD) and require approval from the Therapeutic Goods Administration (TGA) and registration in the Australian Register of Therpeutic Goods (ARTG).


Other Countries

For Medical Equipment approval in other countries, contact Teleconformtiy.


Your Application
If you are familiar how to proceed using the application forms below, please go ahead. In any other case, please contact us here.


   Forms for Medical Equipment    Application forms for Medical Equipment Approval (Class I)


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